Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of claim(s)
Claims 21-40 have been examined. Claims 21, 33-34, 36, 40 have been amended.
Terminal Disclaimer
The terminal disclaimer filed on 11/18/2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US. Patent No. 11491270 and US Patent 12011529 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 21-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tirinato et al. (US. 20090204513A1 hereinafter Tirinato) in view of Laster et al. (WO 2016019345A1 hereinafter Laster).
With respect to Claim 1, Tirinato teaches a medical system, comprising:
a medical treatment machine configured to perform a medical treatment on a patient (‘513; Abstract; Para 0010: Renal dialysis unit);
a rules based engine configured to:
estimate a local inventory of a medical item for the medical treatment (‘513; Paras 0066-0067: the system 300 can provide a real-time or near real-time estimate of remaining inventory in the local inventory 305, based on recognizing a consumption of a device 104 or consumable item by receiving an electronic notification from the reading apparatus 102 of the consumption, as described with reference to FIG. 4),
determine that there is a current or anticipated shortage in quantity of the medical item by comparing (i) the estimated local inventory of the medical item to (ii) information related to a consumption rate of the medical item at the local inventory (‘513; Para 0059: The central repository 302 can compare the number of devices 104 that are available in local inventory 305 to the reading apparatus 102 with a predetermined minimum inventory level for the reading apparatus 102 (block 408). Based on, for example, the consumption rate for a device at a given point-of-care location, the predetermined minimum inventory level for that location can be set; Para 0064:), and
generate, based on the current or anticipated shortage of the medical item, a recommended order for the medical item to be placed, the recommended order including a recommended quantity for the medical item (‘513; Para 0036: the automated system according to exemplary embodiments is capable of initiating automatic reordering of devices of various types from the supplier, in relation to the consumption of devices at a given institution. The automated system can redistribute devices between locations within a hospital when a temporarily inadequate inventory exists at a central location within a hospital, for instance where there is an emergency medical situation causing a spike in demand for devices in one particular department, or where supplies of new devices to the hospital from the supplier have been delayed by a transportation emergency; Para 0071: provide for automated re-ordering of devices 104 to maintain the predetermined levels of inventory at the hospital's central repository 302, and allow the vendor to forecast demand and adequately plan the manufacture of the devices); and
Laster teaches
a control unit configured to:
provide, to a user of the medical treatment machine, an output indicating the recommended order (345; Para 0067: provide for automated re-ordering of devices 104 to maintain the predetermined levels of inventory at the hospital's central repository 302, and allow the vendor to forecast demand and adequately plan the manufacture of the devices),
transmit, to an order management system that is remote from the control unit, an instruction for an order for the medical item based on an input from the user regarding the recommended order (‘345; Para 0166: the input that the patient 602 provides is transmitted over a network to the scheduler 1 10, which stores and processes the information. The scheduler 1 10 may maintain a history of any or all of the patient's interactions with the client app 120 that reflect compliance or lack of compliance.; Para 0265: managing inventory of a medical facility that may include the actions of receiving data indicating use of an item in a medical procedure, in response to receiving data indicating the use of the item, determining that the item should be replaced in the inventory of the medical facility. Based on determining that the item should be replaced, these methods may further include the actions of identifying a price for the item indicated by a contract with a supplier, and transmitting, to the supplier, an order to purchase the item from the supplier at the price indicated by the contract with the supplier; Para 0283: A client and server are generally remote from each other and typically interact through a communication network ).
It would have ben obvious to one of ordinary skill in the art before the effective filing date of claimed invention to modify the system of Tirinato with the technique of providing implants for surgical procedures as taught by Laster and the motivation is to provide medical items for the inventory of treatment machine.
Claims 36 and 40 are rejected as the same reason with claim 21.
With respect to claim 22, the combined art teaches the medical system of claim 21, wherein the control unit is part of the medical treatment machine (‘513; Para 0017).
With respect to claim 23, the combined art teaches the medical system of claim 21, further comprising a gateway device that includes the control unit, wherein the gateway device is configured to communicate with the medical treatment machine through a wireless connection (‘513; Para 0039).
With respect to claim 24, the combined art teaches the medical system of claim 23, wherein the gateway device is configured to communicate with one or more remote systems through a cloud-based application (‘513; Para 0053).
With respect to claim 25, the combined art teaches the medical system of claim 24, wherein the one or more remote systems comprises at least one of the medical treatment machine, the order management system, and the rules based engine (‘513; Para 0053.
With respect to claim 26, the combined art teaches the medical system of claim 23, wherein the gateway device is configured to provide two-way conversational capability between the user and the gateway device by receiving audio from the user and generating a response signal to the user (‘345; Para 00279).
With respect to claim 27, the combined art teaches the medical system of claim 26, further comprising a speaker, wherein the control unit is further configured to cause the speaker to generate a spoken response based on the response signal; receive an audio input from the user; identify one or more spoken words based on the audio input; and cause the medical treatment machine to perform a treatment action based on the identified one or more spoken words (‘345; Para 00279).
With respect to claim 28, the combined art teaches the medical system of claim 21, wherein the recommended order differs from a prior order in at least the recommended quantity of the medical item (‘345; Para 0064: to determine whether inventory levels are appropriate and make recommendations.).
With respect to claim 29, the combined art teaches the medical system of claim 21, wherein the rules based engine is further configured to estimate the local inventory of the medical item at a specific frequency (‘345; Para 0081).
With respect to claim 30, the combined art teaches the medical system of claim 21, further comprising a microphone configured to receive audio input from the user, wherein the control unit is further configured to
identify a user parameter in the audio input received at the microphone, and
cause the medical treatment machine to set or modify a treatment parameter based on the identified user parameter (‘345; Para 0022).
With respect to claim 31, the combined art teaches the medical system of claim 21, wherein the current or anticipated shortage of the medical item is further determined based on one or more of an expected rate of consumption of the medical item, a shipping time of the medical item, a frequency of use of the medical item, an availability of the medical item, an expected delay in shipping of the medical item, or a duration required to ship the medical item (‘513; Para 0059).
With respect to claim 32, the combined art teaches the medical system of claim 21, wherein the rules based engine is located at the medical treatment machine or at the order management system (‘513; Para 0059).
With respect to claim 33, the combined art teaches the medical system of claim 21, wherein the user input includes spoken words (‘513; Para 0055).
With respect to claim 34, the combined art teaches the medical system of claim 21, wherein the user input includes an audio, and wherein the control unit is further configured to identify spoken words in the audio; and generate the instruction based on the identified spoken words (‘345; Para 00279).
With respect to claim 35, the combined art teaches the medical system of claim 21, wherein the medical treatment machine comprises a dialysis machine (‘513; Para 0010: a renal dialysis unit).
With respect to claim 37, the combined art teaches the method of claim 36, further comprising identifying spoken words in the user input, wherein the user input is in form of audio, and wherein the order is placed based on the identified spoken words (‘345; Para 00279).
With respect to claim 38, the combined art teaches the method of claim 36, wherein the local inventory of the medical item is estimated at a predetermined frequency (‘345; Para 0081).
With respect to claim 39, the combined art teaches the method of claim 36, further comprising: receiving audio input from the user; identifying a user parameter in the audio input; and causing a medical treatment machine to set or modify a treatment parameter, or to perform a treatment action based on the identified user parameter (‘513; Para 0057.)
Response to Arguments
Applicant's arguments filed 11/18/2025 have been fully considered but they are not persuasive.
In the Remark filed 11/18/2025, the Applicant argued that, for claim rejection under 35 USC103 ,Laster does not disclose a control unit configured to provide, to a user of the medical treatment machine, an output indicating the recommended order.
However, the Examiner respectfully disagree. In fact, under broadest reasonable interpretation of the recited claim 21, Tirinato discloses, as in FIG. 3, illustrating an inventory control system for controlling an inventory of a plurality of point-of-care diagnostic devices. The system 300 can include a central repository 302, a reading apparatus 102, a local inventory of devices 305, and a device 104 (‘513; Para 0051)
Laster discloses the user interface 400 includes interactive controls 414a, 414b that permit a user to take action to secure the items needed for the surgery (‘345; Para 00151). Laster further describes the predicted model implemented as a set of rule generated to satisfy the needs of the consumable item in the inventory (‘345; Para 00205) and managing inventory of a medical facility that may include the actions of receiving data indicating use of an item in a medical procedure, in response to receiving data indicating the use of the item, determining that the item should be replaced in the inventory of the medical facility (‘345; Para 0265).
The Applicant further argued that the Action is deficient with respect to several dependent claims as well because it did not provide a clear articulation of the reasons for rejecting those claims. For each of claims 22-27, 29, 30-34, and 37-39, the Action has merely cited to a respective paragraph of Tirinato or Laster without explaining why that paragraph would be applicable to the targeted claim (Remark, page 10).
In response to applicant's argument, a recitation of the intended use of the claims 22-27, 29, 30-34, and 37-39 must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Given broadest reasonable interpretation of the recited claims, it is submitted that the inventory control system of Tirinato, the predictive model of Laster are in the form of the rule-based and control unit as described in the invention.
Therefore, the Examiner maintains rejection of recited claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US20140288947, Sep. 25, 2014; Simpson et al.; System and method for communicating with a dialysis machine through a network.
US 20130310726A1, Nov. 21, 2013, Miller et al.; Home Medical Device Systems and Methods for Therapy Prescription and Tracking, Servicing and Inventory.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686